510(k) Device Clearances
Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.
3,400 total clearances
Transorb Self-Gripping Resorbable Mesh
Sofradim Production
ONE-CUF
Ge Medical Systems Information Technologies, Inc.
VS3-Iridium System (VS3-IR)
Visionsense, Ltd.
ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
Luminance Red Cold Sore Device (TN1927G)
Luminance Medical Ventures, Inc.
ArtiSential Laparoscopic Instruments-Electrodes
Livsmed, Inc.
BD Nano 2nd Gen Pen Needle
Becton, Dickinson and Company
aprevo® Digital Segmentation
Carlsmed, Inc.
da Vinci SP Surgical System
Intuitive Surgical, Inc.
prodisc® L Instruments
Centinel Spine, LLC
NxStage PureFlow Solution
Nxstage Medical, Inc.
iFuse Bedrock Granite Implant System
SI-BONE, Inc.
SQA-iO Sperm Quality Analyzer
Medical Electronic Systems , Ltd.
MR 5300
Philips Medical Systems Nederland B.V.
CVAC® Aspiration System
Calyxo, Inc.
Oxygen Concentrator (J5A)
Foshan Kycare Medical Equipment Co., Ltd.
Navilas Laser System 577sl (156691)
Od-Os GmbH
Annalise Enterprise CTB Triage-OH
Annalise-Ai Pty , Ltd.
T-Line® Hernia Mesh
Deep Blue Medical Advances, Inc.
TnR Cranial Implant
T&R BIOFAB CO., Ltd.
NightOwl
Ectosense NV
Trigon PEEK HA Wedges
Nvision Biomedical Technologies
AlphaVac Multipurpose Mechanical Aspiration System F1885
AngioDynamics, Inc.
Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe
CMT Health PTE., Ltd.
Sunny Cup and Applicator
Menstrual Mates
APTUS Elbow Dorsal Olecranon Plates
Medartis AG
Signature Osteosynthesis Plate System
Signature Orthopaedic Pty , Ltd.
Control-IQ+ technology
Tandem Diabetes Care, Inc.
Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Teleport XT Microcatheter
OrbusNeich Medical (Shenzhen) Co., Ltd.
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